Cancer drugs approved by the US FDA have been questioned for insignificant clinical benefits and adverse side effects. This study aims to examine the differences in clinical evidence and benefit of cancer drugs between US FDA and provincial reimbursement in Canada.
This cohort study included data regarding all cancer drugs with a solid tumor indication that had received inception of pCODR. The eligibility criteria for drugs to be included in the study were completed reimbursement decisions from pCODR. Incomplete submissions or those with pending decisions were included. The primary outcome of the study was final reimbursement recommendation, along with trial characteristics and clinical outcomes.
The pCODR issued a total of 104 reimbursement recommendation decisions for cancer drugs that had a solid tumor indication. Of these submissions, 78 received a positive recommendation, 72 of which were conditional. Drugs that received a positive recommendation were more likely to have a phase-3 clinical trial design and substantial benefit compared with those receiving a negative recommendation. Progression-free survival (PFS) and overall survival (OS) were the most common primary endpoints in successful submissions.
The research concluded that only half of the cancer drugs that received pCODR approval had evidence of improved OS and PFS, despite taking into account that pCODR took the magnitude of clinical benefit into account.
Ref: https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2776285?resultClick=1
